Pharmacist, Regulatory Affairs

About DKSH
DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology.
Delivering life-saving drugs to hospitals, bringing high-quality products to remote villages, installing technology that raises living standards, and providing new formulations for healthcare products that make life easier. These are just a few examples of how DKSH touches people’s lives around the clock. We do this while helping our clients and customers grow by providing services including sourcing, market insights, marketing and sales, eCommerce, distribution and logistics as well as after-sales services.
Listed on the SIX Swiss Exchange, DKSH operates in 36 markets with 33,100 specialists, generating net sales of CHF 11.1 billion in 2021. Founded by Swiss entrepreneurs in 1865, we have been deeply rooted in Asia Pacific for over 150 years.

Why It’s Great to Work at DKSH
Join a purpose-driven company and help enrich people’s lives every day. We provide reliable access to high-quality products and services, like COVID-19 vaccines, and create sustainable value for all our stakeholders, generate jobs, and give back to society. Founded over 150 years ago in Asia by three Swiss traders, DKSH still maintains the same entrepreneurial mindset. Be part of our diverse team of more than 33,000 people working in 36 markets across the globe. You will learn and develop both professionally and personally in a modern environment offering hybrid work arrangements. Come and meet our energetic, passionate, and purposeful team and be part of something big.

Job Summary
- Responsible for daily operation of controlled drug management and pharmacovigilance, regulatory submission for special access routes, controlled drug and psychotropics licences for the Healthcare Business Unit of DKSH Singapore.
- Ensure operational procedures are in compliant with the requirements of the local Regulatory Authorities
- Registered pharmacist for the Form A and Controlled Drug Licenses

General Responsibilities
Controlled Drug Management
- Supervise controlled drug distribution: inbound and outbound
- Ensure supply is according to Misuse of Drug Regulation
- Ensure stock balances are 100% accountable with daily and monthly stock count
- Ensure records are maintained as per Misuse of Drug Regulation
- Responsible for annual reporting to HSA
- Manage CD destruction
- Responsible for CD training to relevant staff
- Manage HSA and client audits

Pharmacovigilance (PV)
- Acts as the Local Primary Pharmacovigilance Responsible Person
- Receive and review individual case safety report (ICSRs) for accuracy and completeness.
- Follow up with reporter for clarification and completion when necessary
- Report ICSR and safety information to clients and health authority within stipulated timelines
- Coordinate with clients and relevant functions for FSCA reporting to health authority within stipulated timelines
- Responsible for PV reconciliation with clients
- Manage client audit
- Responsible for pharmacovigilance training
- Manage PV activities according to standard procedures, pharmacovigilance agreement and local regulations

Operations
- Document Controller for the department
- Manage department’s SOPs and training records
- Ensure compliance to the licensing requirements in the importation, wholesale and distribution of health products:

- focusing on the management of authorised activities and the accuracy and quality of records
- ensuring that suppliers and customers are legally approved or authorised to enable lawful supply of health products

Job Requirements
- Registered Pharmacist with Singapore Pharmacy Council
- More than 2 years of experience in the pharmaceutical industry

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